Table 4.
Combination clinical trials with idelalisib in patients with NHL
| Study drugs (clinical trials # for ongoing studies) | Phase 1, 2, or 3 (Number of patients) | Patient population (median age) | OR | Median PFS | Reference |
|---|---|---|---|---|---|
| Monoclonal antibody combinations | |||||
| R-idelalisib (NCT01088048) | Phase 1/2 (32) | R/R indolent NHL (61) | 75% (CR 25%) | 29.7 months | De Vos36 |
| R-idelalisib (NCT02258529) | Phase 2 (50) | Front-line FL and SLL | Ongoing | Ongoing | |
| R-idelalisib vs. R-placebo (NCT01732913) | Phase 3 (375) | R/R indolent NHL | Ongoing | Ongoing | |
| Cytotoxic chemotherapy combination | |||||
| Bendamustine & idelalisib (NCT01088048) | Phase 1/2 (33) | R/R indolent NHL (61) | 88% (CR 36%) | 32.8 months | De Vos36 |
| R-Bendamustine and idelalisib (NCT01088048) | Phase 1/2 (14) | R/R indolent NHL (61) | 79% (CR 43%) | 37.1 months | De Vos36 |
| R-bendamustine and idelalisib vs. R-bendamustine + placebo (NCT01732926) | Phase 3 (450) | R/R Indolent NHL | Ongoing | Ongoing | |
| Immunomodulatory and other agent combinations | |||||
| R-lenalidomide, idelalisib (Alliance 051201, NCT01838434) | Phase 1 (1) | R/R MCL | CLOSED DUE TO SEVERE INFUSIONALTOXICITY | Smith38 | |
| R-lenalidomide, idelalisib (Alliance 051202, NCT01644799) | Phase 1 (7) | R/RFL | CLOSED DUE TO SEVERE INFUSIONALTOXICITY | Smith38 | |
Abbreviations: OR: Overall response; PFS: Progression-free survival; R/R: relapsed/refractory; NHL: non-Hodgkin's lymphoma; CR: complete response; FL: follicular lymphoma; SLL: small lymphocytic lymphoma; MCL: Mantle cell lymphoma.